510(k) · Cleared
ClearedInion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion OY · HBW Fastener, Plate, Cranioplasty
Cleared on Jul 11, 2025 as substantially equivalent to K010352 (Inion, Ltd., 2001) and 3 other predicates after a 59-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jul 11, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- HBW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K010351 (2001). 8 ancestors in all, the oldest K971870 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010351 | Inion CPS Baby 1.5 Bioabsorbable Fixation System | Inion, Ltd. | 2001 | 2 |
| −1 | K033194 | Inion CPS Baby 1.5 Bioabsorbable System | Inion, Ltd. | 2003 | — |
| 0 (this device) | K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby… | Inion OY | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBW device
- #1 K231208 Stryker Resorbable Fixation Systemscore 8.2 · 9 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010352 | CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemSummary page 5…tion System Predicate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010352 Predicate Device Classification & Name 872.4760 Plate, Bone Predicate Device Classification & Class II 510(k)… | 2001 |
| * | K033194 | Inion CPS Baby 1.5 Bioabsorbable SystemSummary page 5…tem Predicate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K01035, K033194, K051341, K052444 Predicate Device Classification & Name 872.4760 Plate, Bone Predicate Device Classification &… | 2003 |
| * | K051341 | Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058…Summary page 5…icate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K01035, K033194, K051341, K052444 Predicate Device Classification & Name 872.4760 Plate, Bone Predicate Device Classification & Class I… | 2005 |
| * | K052444 | Inion CPS Baby 1.5 Bioabsorbable Fixation SystemSummary page 5…ice Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K01035, K033194, K051341, K052444 Predicate Device Classification & Name 872.4760 Plate, Bone Predicate Device Classification & Class II 510(k)… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 21.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 8 other devices also cite its predicate K010352.
How does its category compare?
All HBW devicesHBW Fastener, Plate, Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HBW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBW
Too few HBW 510(k)s in any year since 2007 to give a median.
Recalls per year · HBW
No recall names HBW since 2007.
Adverse event reports per year · HBW
3in 2025
MAUDE reports naming product code HBW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla.
The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251472: Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026